Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD).

BACKGROUND: Functional abdominal pain disorders (FAPD) are the most common chronic pain conditions of childhood and are made worse by co-occurring anxiety. Our research team found that the Aim to Decrease Pain and Anxiety Treatment (ADAPT), a six-session coping skills program using cognitive behavioral therapy strategies, was effective in improving pain-related symptoms and anxiety symptoms compared to standard care. In follow-up, this current randomized clinical trial (RCT) aims to test potential neural mechanisms underlying the effect of ADAPT. Specifically, this two-arm RCT will explore changes in amygdalar functional connectivity (primary outcome) following the ADAPT protocol during the water loading symptom provocation task (WL-SPT). Secondary (e.g., changes in regional cerebral blood flow via pulsed arterial spin labeling MRI) and exploratory (e.g., the association between the changes in functional connectivity and clinical symptoms) outcomes will also be investigated. METHODS: We will include patients ages 11 to 16 years presenting to outpatient pediatric gastroenterology care at a midwestern children's hospital with a diagnosis of FAPD plus evidence of clinical anxiety based on a validated screening tool (the Generalized Anxiety Disorder-7 [GAD-7] measure). Eligible participants will undergo baseline neuroimaging involving the WL-SPT, and assessment of self-reported pain, anxiety, and additional symptoms, prior to being randomized to a six-week remotely delivered ADAPT program plus standard medical care or standard medical care alone (waitlist). Thereafter, subjects will complete a post assessment neuroimaging visit similar in nature to their first visit. CONCLUSIONS: This small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT. TRIAL REGISTRATION: ClinicalTrials.gov registration: NCT03518216.

Psychological distress and coping efficacy in children with disorders of gut-brain interaction.

BACKGROUND: Multiple psychological factors influence disorders of gut-brain interaction (DGBIs). We aimed to evaluate psychological distress in Colombian schoolchildren with and without DGBIs. METHODS: We included children ages 8-18 years without organic medical conditions from largest regional public schools in Colombia. Children completed Spanish versions of Rome III diagnostic questionnaire for DGBIs, State Trait Anxiety Inventory for Children (STAIC), Children's Somatization Inventory (CSI), and a measure of coping efficacy. These data, demographic and socioeconomic characteristics, were compared between children with DGBIs and healthy peers. Exploratory analyses investigated differences between youth with symptoms of functional abdominal pain disorders (FAPDs) compared with healthy peers. KEY RESULTS: Of 1496 children, 281 (mean age 12.9 ± 2.2 years, 49.8% females) self-reported criteria for DGBIs and 125 reported (44.5%) FAPDs. Children with DGBIs had higher trait anxiety, emotional sensitivity, somatization including GI, non-GI, pain-related, and non-pain-related subscales (p < 0.001 each) and lower coping efficacy (p = 0.02) compared to healthy peers. Females had higher trait anxiety and somatization (p = 0.04 and p = 0.005, respectively). State and trait anxiety and coping efficacy differed based on location in children with DGBIs (p = 0.02, p = 0.03, and p < 0.001, respectively). Children with FAPDs had higher trait anxiety (p = 0.02) and somatization (p < 0.001) compared to healthy youth. CONCLUSIONS & INFERENCES: Children with DGBIs had higher anxiety, emotional sensitivity, and somatization, and lower coping efficacy compared with healthy youth. This highlights the importance of appraising psychological distress characteristics as well as incorporating conflict resolution, assertiveness training, and resilience building during the treatment of DGBIs.

Commentary: Actionable Steps for Addressing Pediatric Pain in Rural and Underserved Communities: Disrupting Our Approach to Psychological Science and Care.

Although chronic pain is one of the most common health issues affecting children, disparities in access to behavioral healthcare limit its proper identification and management. There is a critical need to move beyond traditional care delivery approaches for chronic pain to reach those in communities that have limited access to care. We argue one means of doing so is to leverage our skills and expertise as psychologists to partner with and train professionals who have established relationships with youth in these communities. Drawing from a community-engaged dissemination and implementation science framework and our research implementing pain management strategies in rural and underserved communities, we review actionable strategies for disrupting traditional psychological methods to expand access to care for children with chronic pain.

A multi-site pilot randomized clinical trial of the Treatment and Education Approach for Childhood-onset Lupus (TEACH) program: study design and COVID-19 adaptations.

BACKGROUND: Childhood-onset Systemic Lupus Erythematosus (cSLE) is an autoimmune disease associated with fatigue, mood symptoms, and pain. Fortunately, these symptoms are potentially modifiable with psychological intervention such as cognitive-behavioral therapy (CBT). The Treatment and Education Approach for Childhood-onset Lupus (TEACH) program is a CBT intervention developed to target these symptoms for adolescents and young adults with cSLE. This pilot randomized controlled trial (RCT) aims to determine the feasibility and effect of TEACH for youth with cSLE. Adjustments to the study protocol following the COVID-19 pandemic are also described. METHODS: This two-arm multisite RCT will explore the feasibility (primary outcome) and effect (secondary outcome) of a remotely delivered TEACH protocol. Participants will be randomized to a six-week remotely delivered TEACH program plus medical treatment as usual (TAU) or TAU alone. We will include patients ages 12-22 years presenting to rheumatology clinics from six sites. Validated measures of fatigue, depressive symptoms, and pain will be obtained at baseline and approximately eight and 20 weeks later. Protocol adjustments were also made due to the COVID-19 pandemic, in collaboration with the investigative team, which included patients and caregivers. CONCLUSIONS: Findings from this multi-site RCT aim to document the feasibility of TEACH and provide an estimate of effect of a remotely delivered TEACH protocol on fatigue, depression, and pain symptoms in youth with cSLE as compared to standard medical treatment alone. This findings may positively impact clinical care for patients with cSLE. CLINICAL TRIALS: gov registration: NCT04335643.

An ecological approach to understanding and addressing health inequities of systemic lupus erythematosus.

Systemic Lupus Erythematosus (SLE) is a complex chronic autoimmune disease disproportionally afflicting women and, in particular, American Indian/Alaska Native, Black, and Hispanic women. These groups of women have significantly worse SLE-related health outcomes which are partially attributable to their exposure to marginalizing and interconnecting social issues like racism, sexism, economic inequality, and more. Although these groups of women have higher rates of SLE and though it is well known that they are at risk of exposure to marginalizing social phenomena, relatively little SLE literature explicitly links and addresses the relationship between marginalizing social issues and poor SLE-health outcomes among these women. Therefore, we developed a community-engaged partnership with two childhood-SLE diagnosed women of color to identify their perspectives on which systemic issues impacted on their SLE health-related outcomes. Afterward, we used Cochrane guidelines to conduct a rapid review associated with these identified issues and original SLE research. Then, we adapted an ecological model to illustrate the connection between systems issues and SLE health outcomes. Finally, we provided recommendations for ways to research and clinically mitigate SLE health inequities.

Amygdalar functional connectivity during resting and evoked pain in youth with functional abdominal pain disorders.

ABSTRACT: Pediatric functional abdominal pain disorders (FAPD) are highly prevalent, difficult to diagnose, and challenging to treat. The brain systems supporting FAPD remain poorly understood. This investigation examined the neuromechanisms of FAPD during a well-tolerated visceral pain induction task, the water load symptom provocation task (WL-SPT). Youth between the ages of 11 and 17 years participated. Functional connectivity (FC) was examined through the blood oxygenation level-dependent effect using the left and right amygdala (AMY) as seed regions. Relationships of the time courses within these seeds with voxels across the whole brain were evaluated. Arterial spin labeling was used to assess regional brain activation by examining cerebral blood flow. Increased FC between the left AMY with regions associated with nociceptive processing (eg, thalamus) and right AMY FC changes with areas associated with cognitive functioning (dorsolateral prefrontal cortex) and the default mode network (DMN; parietal lobe) were observed in youth with FAPD after the WL-SPT. These changes were related to changes in pain unpleasantness. Amygdala FC changes post-WL-SPT were also related to changes in pain intensity. Amygdala FC with the DMN in youth with FAPD also differed from healthy controls. Global cerebral blood flow changes were also noted between FAPD and healthy controls, but no significant differences in grey matter were detected either between groups or during the WL-SPT in youth with FAPD. Findings confirm youth with FAPD undergo changes in brain systems that could support the development of biomarkers to enhance understanding of the mechanisms of pain and treatment response.

Non-pharmacologic therapies in treatment of childhood-onset systemic lupus erythematosus: A systematic review.

BACKGROUND: Childhood-onset systemic lupus erythematosus (cSLE) is a complex multisystem autoimmune disease often associated with pain, fatigue, and mood-related disturbances. cSLE is associated with increased disease severity and higher rates of mortality as compared to adult onset SLE. Therefore, a multi-faceted approach to care, including the use of non-pharmacologic therapies, is essential to ensure optimal patient outcomes. The use of non-pharmacologic therapies as adjunctive treatments has been shown to be beneficial in adults with SLE, yet, their use and effect is less well understood in cSLE. This is the first systematic review to explore the use and quality of evidence of non-pharmacologic approaches to treat cSLE. METHODS: A literature review was performed using PRISMA guidelines. Studies until March 2021 with participants diagnosed with cSLE were included. The quality of the evidence was graded via OCEBM levels of evidence guidelines and bias assessed using Cochrane guidelines. Completed clinical trials (via clinicaltrials.gov) were also searched to identify unpublished results. RESULTS: Eleven published studies consisting of 1152 patients met inclusion criteria for this review, as well as three additional studies with unpublished data on clinicaltrial.gov. Of the published trials, four studies used patient education/support, three studies used dietary supplementation, three used forms of psychotherapy (e.g., Cognitive behavioral therapy), and 1 used aerobic exercise to target the following issues: treatment adherence (n = 3), quality of life (n = 3), fatigue (n = 2), pain (n = 2), depressive symptoms (n = 1), anxiety (n = 1), and health-related outcomes including disease severity (n = 3), cardiovascular disease risk (Cardiovascular disease; n = 3), and muscle function (n = 1). Across investigations, the quality of the evidence based on study design was moderate/low. In terms of potential outcomes, dietary supplementation methods were successful in 2 of 3 studies and were associated with improvements in disease activity and fatigue. Aerobic exercise was effective in decreasing resting heart rate and increasing cardiorespiratory capacity. Patient education/support was related to significantly increased treatment adherence and decreased cardiovascular risk markers. Two of the three studies examining the impact of psychotherapy showed improvements (e.g., in treatment adherence, depression and fatigue). CONCLUSION: This review identifies several promising non-pharmacologic therapies to use as adjunctive treatments to traditional pharmacologic regimens in health and mental health-related outcomes in patients with cSLE. Future well controlled clinical trials would be beneficial to more rigorously evaluate the effects of non-pharmacologic therapies in pediatric populations.

Effect of percutaneous electrical nerve field stimulation on mechanosensitivity, sleep, and psychological comorbidities in adolescents with functional abdominal pain disorders.

BACKGROUND: Percutaneous electrical nerve field stimulation (PENFS) improves symptoms in adolescents with functional abdominal pain disorders (FAPDs). However, little is known about its impact on sleep and psychological functioning. We evaluated the effects of PENFS on resting and evoked pain and nausea, sleep and psychological functioning, and long-term outcomes. METHODS: Patient ages 11-19 years with FAPD requiring PENFS as standard care were recruited. Evoked pain was elicited by a Water Load Symptom Provocation Task (WL-SPT) before and after four weeks of treatment. Pain, gastrointestinal symptoms, sleep, somatic symptoms, and physical and psychological functioning were assessed. Actigraphy was used to measure daily sleep-wake patterns. KEY RESULTS: Twenty patients (14.3 ± 2.2 years old) with FAPD were enrolled. Most patients were females (70%) and white (95%). During pain evoked by WL-SPT, visual analog scale (VAS) pain intensity and nausea were lower following PENFS compared with baseline (p = 0.004 and p = 0.02, respectively). After PENFS, resting VAS pain unpleasantness (p = 0.03), abdominal pain (p < 0.0001), pain catastrophizing (p = 0.0004), somatic complaints (0.01), functional disability (p = 0.04), and anxiety (p = 0.02) exhibited significant improvements, and some were sustained long-term. Self-reported sleep improved after PENFS (p's < 0.05) as well as actigraphy-derived sleep onset latency (p = 0.03). CONCLUSIONS AND INFERENCES: We demonstrated improvements in resting and evoked pain and nausea, sleep, disability, pain catastrophizing, somatic complaints, and anxiety after four weeks of PENFS therapy. Some effects were sustained at 6-12 months post-treatment. This suggests that PENFS is a suitable alternative to pharmacologic therapy.

Mental Health in Pediatric Rheumatology: An Opportunity to Improve Outcomes.

Mental health problems are more common in children with pediatric rheumatologic diseases (PRDs) than healthy peers. Mental health problems affect disease-related outcomes and health-related quality of life (HRQOL), so addressing these problems can improve clinical and psychosocial outcomes. Mental health screening tools are available, and there are resources available to aid in integrating mental health care into the clinical setting. By implementing these tools, mental health problems can be recognized and addressed.

Child-Focused Cognitive Behavioral Therapy for Pediatric Abdominal Pain Disorders Reduces Caregiver Anxiety in Randomized Clinical Trial.

Pediatric functional abdominal pain disorders (FAPD) are associated with elevated anxiety in youth and their caregivers, both contributing to an adverse impact on functioning in youth with FAPD. While a CBT approach (ie, Aim to Decrease Anxiety and Pain Treatment [ADAPT]) is known to improve health outcomes for youth, it is unknown if child-focused treatment improves caregiver anxiety. This secondary analysis of a larger randomized clinical trial examined if child-focused CBT (ADAPT) for pain and anxiety also impacts caregiver anxiety and explored the relation between caregiver anxiety and child symptoms (ie, pain, disability, anxiety) after treatment. A total of 79 caregiver-child dyads were randomized to ADAPT plus treatment as usual (TAU) or TAU only. Caregiver anxiety and child outcomes (pain, disability, anxiety) were assessed at baseline and approximately 8 weeks later. Caregivers of children who completed ADAPT+TAU demonstrated lower anxiety compared to those who only received TAU. Moreover, regardless of treatment assignment, caregivers with greater anxiety had children who reported more pain and anxiety, but not functional disability at post-assessment. Results suggest a brief, child-focused intervention targeting pain and anxiety may also improve caregiver anxiety. As such, suggestions to improve future treatments are offered. PERSPECTIVE: Caregiver anxiety symptoms diminished after their child with functional abdominal pain completed a course of child-focused CBT targeting pain and anxiety. Further, caregiver anxiety was related to child-reported symptoms (pain and anxiety) after treatment. Therefore, improved caregiver mental health via a child-focused CBT may also improve pediatric outcomes.

A Scoping Review and Proposed Framework for Coping in Youth With a History of Psychological Trauma and Chronic Pain.

OBJECTIVE: Psychological trauma (e.g., abuse, neglect) and posttraumatic stress symptoms (PTSS) commonly occur in pediatric pain populations and may be related to various maladaptive coping strategies, which may in turn affect short- and long-term pain-related outcomes in youth. Accordingly, the current scoping review and conceptual framework seeks to identify important gaps in the field's current understanding of how coping impacts outcomes in youth who have experienced trauma/PTSS and pediatric chronic pain and explores avenues for future investigation. METHODS: A scoping review of the literature was performed in Medline, Embase, Cochrane Library, PsycInfo, and Sociological Abstracts. Eligibility criteria included pediatric populations experiencing chronic pain, trauma, adverse childhood events, and/or PTSS and associated coping mechanisms. Nine research papers were selected and used to support the conceptual framework. The framework builds upon the work of Compas et al.'s' model of control-based coping (Compas et al., 2006; Compas & Harding Thomsen, 1999) and outlines the potential effects of trauma and/or PTSS and pain on coping and pain-related outcomes (e.g., pain chronicity, functional outcomes) in pediatric chronic pain populations. RESULTS: A history of chronic pain and psychological trauma and/or PTSS in youth may contribute to increased risk for maladaptive coping and in turn, poorer pain-related and psychosocial outcomes long-term. CONCLUSIONS: Findings from the current scoping review and proposed conceptual framework will guide future research and treatment efforts for youths experiencing pain and trauma and/or PTSS and thereby enhance long-term outcomes.

Establishing Clinical Cut-points on the Pediatric PROMIS-Pain Interference Scale in Youth With Abdominal Pain.

OBJECTIVE: Abdominal pain is a common presenting complaint in youth seeking medical care and can be debilitating. Therefore, it is important to understand the impact of pain on functioning using a clinically sensitive approach. The National Institutes of Health has established a common core of psychometrically precise measures through the Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. The Pediatric PROMIS-Pain Interference (PPPI) scale was developed to measure pain-related interference, drawing from existing legacy measures. However, its clinical validity has not been thoroughly established in clinical populations. The current study sought to develop clinical cut-points and investigate the validity of the PPPI in a large sample (N=5281) of youth presenting to gastroenterological care with abdominal pain symptoms. MATERIALS AND METHODS: Convergent validity of the PPPI was investigated. Quartile and tertile groupings of the PPPI were calculated and compared with cut-points derived from healthy populations and mixed convenience samples on clinical outcomes via multivariate analyses of variance. RESULTS: There was good evidence of convergent validity. The tertile solution was superior in classifying different levels of pain-related outcomes as compared with other cut-points. The tertile solution suggested the following PPPI groupings: minimal (≤51), moderate (52 to 59), and severe (≥60). DISCUSSION: Results suggest the PPPI is a valid measure with clinically meaningful cut-points to assess pain-related interference in youth with abdominal pain.

Evaluating Telehealth Implementation in the Context of Pediatric Chronic Pain Treatment during COVID-19.

Telehealth has emerged as a promising healthcare delivery modality due to its ability to ameliorate traditional access-level barriers to treatment. In response to the onset of the novel coronavirus (COVID-19) pandemic, multidisciplinary pain clinics either rapidly built telehealth infrastructure from the ground up or ramped up existing services. As the use of telehealth increases, it is critical to develop data collection frameworks that guide implementation. This applied review provides a theoretically-based approach to capitalize on existing data sources and collect novel data to inform virtually delivered care in the context of pediatric pain care. Reviewed multisource data are (1) healthcare administrative data; (2) electronic chart review; (3) clinical health registries; and (4) stakeholder feedback. Preliminary telehealth data from an interdisciplinary pediatric chronic pain management clinic (PPMC) serving youth ages 8-17 years are presented to illustrate how relevant implementation outcomes can be extracted from multisource data. Multiple implementation outcomes were assessed, including telehealth adoption rates, patient clinical symptoms, and mixed-method patient-report telehealth satisfaction. This manuscript provides an applied roadmap to leverage existing data sources and incorporate stakeholder feedback to guide the implementation of telehealth in pediatric chronic pain settings through and beyond COVID-19. Strengths and limitations of the modeled data collection approach are discussed within the broader context of implementation science.

Engagement during a Mixed In-Person and Remotely Delivered Psychological Intervention for Youth with Functional Abdominal Pain Disorders and Anxiety.

Functional abdominal pain disorders (FAPD) are common disabling pain conditions frequently associated with co-occurring mental health problems such as anxiety. Psychological therapies such as cognitive behavioral therapy (CBT) have been shown to be effective. Therefore, it is important to understand participant engagement (i.e., use of intervention tools) to such approaches, and if engagement impacts treatment response. The Aim to Decrease Anxiety and Pain Treatment (ADAPT) is an effective psychological treatment approach using a blend of in-person sessions and interventionist phone support with self-paced web modules to manage pain and anxiety. The current study used a mixed-methods approach to investigate micro-level and macro-level participant engagement during the ADAPT program. In-person/phone session attendance was high (>95%) although scheduling adjustments were common (25.5%). Varied levels of engagement with web tools were observed. Thematic analysis also revealed variability in patterns of use. Additionally, while participants indicated they generally understood how to use certain skills (e.g., problem solving, detective thinking), and these skills were effective in managing symptoms during treatment, these activities were generally underutilized. Further, participant engagement did not predict response to the ADAPT intervention. These findings are important as the demand for accessible psychotherapeutic tools to manage pain and anxiety is likely to remain high.

Elevated fecal calprotectin is linked to psychosocial complexity in pediatric functional abdominal pain disorders.

OBJECTIVE: Children with functional abdominal pain disorders (FAPD) and clinical elevations in three risk areas (anxiety, functional disability, and pain) have been found to be at increased risk for persistent disability. We evaluated if the presence of these three risk factors corresponded with greater gastrointestinal inflammation (measured via fecal calprotectin; FC) compared to those with no risk factors. FC concentration differences between children with three risk factors and those with one and two risk factors were explored. RESULTS: Fifty-six children with FAPD (Mage = 12.23) completed measures of anxiety (Screen for Child Anxiety Related Disorders), disability (Functional Disability Inventory), and pain intensity (Numeric Rating Scale). Participants were stratified into risk groups (range: 0-3). Fisher's exact tests were conducted to determine if children with three versus fewer risk factors were more likely to have elevated FC (≥ 50 µg/g) versus normal levels. Children with three risk factors (MFC = 86.04) were more likely to have elevated FC compared to children with zero (MFC = 25.78), one (MFC = 38.59), and two risk factors (MFC = 45.06; p's < 0.05). Those with three risk factors had borderline elevated FC concentrations whereas those with fewer had normal FC concentrations. Findings suggest the importance of a biopsychosocial approach to help elucidate a FAPD phenotype.

Addressing Pediatric Mental Health Using Telehealth During Coronavirus Disease-2019 and Beyond: A Narrative Review.

The pediatrician serves as a frontline provider addressing patients' medical and mental health needs, yet coronavirus disease-2019 (COVID-19) is reshaping the way physicians deliver care. Pediatricians are increasingly faced with the challenge of delivering care, including mental health care, remotely. Given the rapidly evolving literature, we performed a narrative review of the use of telehealth for mental health care for pediatric populations during the COVID-19 pandemic. Areas of focus included 1) pediatric primary care settings, 2) special pediatric populations (eg, eating disorders, autism), 3) access and engagement in telehealth care, and 4) training opportunities available for mental health providers. Themes that emerged across studies included the importance of meeting patients' needs (eg, access to technological resources) to optimize success in using telehealth tools and challenges around provider access to support tools for use during telehealth. Thus, we provided a summary of evidence-based tools (including COVID-19 specific resources) for improving the remote delivery of mental health care by pediatricians. We also reviewed future directions including trials currently underway to enhance understanding of future telehealth applications for pediatric mental health care.

The Utility of an Anxiety Screening Measure in Youth With Functional Abdominal Pain Disorders and Clinical Characteristics Associated With Presence of Anxiety.

OBJECTIVES: Anxiety is common in youth with functional abdominal pain disorders (FAPD) and is related to increased pain-related impairment. However, it is unknown if self-reported anxiety on a clinical screener represents a true anxiety disorder diagnosis in youth with FAPD. Further, little is known about clinical characteristics in youth with FAPD and comorbid anxiety (ANX). Therefore, we evaluated whether the clinical cutoff on the Screen for Anxiety and Related Disorders (SCARED) corresponded with the presence of an anxiety disorder. We predicted a more clinically complex profile (eg, increased pain-related impairment, psychological problems, and family risk factors) in youth with FAPD+ANX compared with youth with FAPD alone. MATERIALS AND METHODS: Participants completed measures of anxiety, functional disability, pain intensity, pain catastrophizing, and mood, and underwent a semistructured diagnostic interview to assess for psychological disorders. Caregivers completed family characteristics and caregiver distress measures. Analyses of group differences were conducted using χ2 and multivariate tests. RESULTS: The SCARED appears to be a good proxy for an anxiety disorder in youth with FAPD, particularly for generalized anxiety disorder and social anxiety disorder. Youth with FAPD+ANX reported higher rates of pain-related disability and depressive symptoms compared with those with FAPD alone, but other clinical characteristics and family risk factors were comparable across groups. DISCUSSION: Findings support the use of the SCARED as a proxy for an anxiety disorder diagnosis in youth with FAPD and suggest youth with FAPD+ANX may have a more complex clinical profile categorized by greater mental health and health-related impairment as compared with youth with FAPD alone.

Cognitive Behavior Therapy Tailored to Anxiety Symptoms Improves Pediatric Functional Abdominal Pain Outcomes: A Randomized Clinical Trial.

OBJECTIVES: To evaluate the feasibility of a stepped care model, and establish the effect of a tailored cognitive behavioral therapy, the Aim to Decrease Anxiety and Pain Treatment (ADAPT), compared with standard medical treatment as usual on pain-related outcomes and anxiety. STUDY DESIGN: Eligible patients between the ages of 9 and 14 years with functional abdominal pain disorders (n = 139) received enhanced usual care during their medical visit to a gastroenterologist. Those that failed to respond to enhanced usual care were randomized to receive either a tailored cognitive behavioral therapy (ADAPT) plus medical treatment as usual, or medical treatment as usual only. ADAPT dose (4 sessions of pain management or 6 sessions of pain and anxiety management) was based on presence of clinically significant anxiety. Outcomes included feasibility, based on recruitment and retention rates. Response to ADAPT plus medical treatment as usual vs medical treatment as usual on pain-related outcomes and anxiety measures was also investigated using a structural equation modeling equivalent of a MANCOVA. Anxiety levels and ADAPT dose as moderators of treatment effects were also explored. RESULTS: Based on recruitment and retention rates, stepped care was feasible. Enhanced usual care was effective for only 8% of youth. Participants randomized to ADAPT plus medical treatment as usual showed significantly greater improvements in pain-related disability, but not pain levels, and greater improvements in anxiety symptoms compared with those randomized to medical treatment as usual only. Anxiety and ADAPT treatment dose did not moderate the effect of treatment on disability nor pain. CONCLUSIONS: Tailoring care based on patient need may be optimal for maximizing the use of limited psychotherapeutic resources while enhancing care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03134950.

Development and Psychometric Evaluation of the PROMIS Pediatric Pain Intensity Measure in Children and Adolescents with Chronic Pain.

The goal of the current study was to enhance the measurement of the pediatric chronic pain experience through a methodologically rigorous approach. This paper outlines the development and initial validation of a pain intensity measure for pediatric patients with chronic pain using Patient-Reported Outcomes Measurement Information System methodology. Measure development incorporated feedback from children with painful conditions. Based on input from pediatric participants and content experts, 4 candidate items assessing pain intensity were included for large scale testing. Children completed self-report items pertaining to their pain experience that were developed as part of a larger pool of new candidate Patient-Reported Outcomes Measurement Information System pediatric pain domain items as well as measures of pain interference, depressive symptoms, fatigue, pain behavior, pain intensity, and pain catastrophizing. The final sample for the large scale testing included N = 442 pediatric patients between the ages 8 to 18 years (Mean age = 13.54, Standard Deviation = 2.78; 71.27% female) experiencing chronic pain. Psychometric analysis resulted in a final measure that included 3 items with evidence of reliability (Cronbach alpha = .82) and convergent validity. The Likert format of the response options may be preferable to the traditional numeric rating scale for use in pediatric populations who experience chronic pain based on patients' feedback, which was directly utilized in designing the scale. Further, the inclusion of fewer and clinically meaningful response options should reduce ambiguity for young respondents. PERSPECTIVE: We have developed and evaluated a clinically sensitive and psychometrically precise 3-item pain intensity measure with Likert-type responses for self-report use among children and adolescents ages 8 to 18 years with chronic pain. Development of the item content and response options included input from children and adolescents with chronic pain. The development of pain intensity items with pediatric appropriate language, and labeled, fewer response options to yield maximal clinically meaningful information improves the precision of pain intensity measurement in children.